Atellica Sample Handler Prime, Material Number 11069001
Check against the official notice below — it lists the full affected range.
Siemens Healthcare Diagnostics, Inc. is recalling the Atellica Sample Handler Prime (Material Number 11069001) due to multiple issues identified in the system software that required an update. A total of 474 units were affected. The device was distributed across numerous U.S. states including California, Texas, Florida, and New York, as well as Puerto Rico and multiple foreign countries including Canada, Australia, Brazil, and others.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
There were multiple issues identified in the system software which required an update.
Reason for recall: There were multiple issues identified in the system software which required an update. Distribution: The products were distributed to the following US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NE, NH, NM, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, WA, WV, WY, and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Do Quantity: 474 Lot/code info: UDI: 00630414002026
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.